German drug giant Bayer AG said Wednesday that the U.S. launch of its new product Vardenafil will be delayed pending more clinical data, dealing another blow to its ailing pharmaceuticals division. The U.S. Food and Drug Administration (FDA) asked for additional clinical pharmacology studies before it grants final approval. Bayer is under pressure to fill its gaping pipeline after the highly publicized withdrawal of its anticholesterol drug Baycol last year, and threatened by generic competition.

The FDA also found a violation of the Federal Food, Drug, and Cosmetic Act by Bayer (see letter below).

To Mary Ellen Evanich Bayer Corporation, West Haven

As part of its routine monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified certain promotional activities by Bayer Corporation (Bayer) that are in violation of the Federal Food, Drug, and Cosmetic Act (Act). Specifically, Bayer is promoting its investigational new drug, vardenafil, as safe or effective for erectile dysfunction at its promotional exhibit booth at the 96th annual meeting of the American Urological Association (AUA) in Anaheim.

Section 21 CFR 312.7 states, among other things, that an investigational new drug may not be promoted as being safe or effective for the uses under investigation. Your exhibit booth at AUA includes posters describing the safety or effectiveness of vardenafil, an investigational treatment for erectile dysfunction. For example, you present claims including, but not limited to, "vardenatil was generally safe and well tolerated and had no clinically significant influence on physical examination, vital signs, or electrocardiogram and laboratory parameters," "...investigators concluded that there was convincing evidence that the clinical activity of vardenafil was consistent with its high selectivity and had a favorable adverse event profile," "vardenafil is a potent and selective inhibitor of PDE5," and "...compared with placebo, oral treatment with 20 or 40 milligrams of vardenafli resulted in earlier, longer-lasting erections with better rigidity and tumescence following visual stimulation." These claims concerning the safety or effectiveness of your investigational product are violative.

Moreover, your representatives are disseminating a poster book and an audiocassette at your exhibit booth that include the same or similar violative claims and representations.

In order to address these objections, DDMAC requests that Bayer immediately discontinue the use of these, and all promotional materials and activities for vardenafil that contain the same or similar violations. Bayer's written response, indicating its intent to comply with this request, should be received on or before June 20, 2001. This response should include a list of all similarly violative promotional materials and your method for discontinuing their use.

If you have any questions or comments, please contact the undersigned by facsimile at (301) 594-C'71, or at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, HFD42, Rm. 1711-20, 5600 Fishers Lane, Rockville, MD 20857. DDMAC reminds you that only written communications are considered official.

In all future correspondence regarding this particular matter, please refer to MACMIS ID #10099 iii addition to the IND number.